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This page describes products and general use; it is not medical advice.
A Malecot catheter is a self-retaining drainage tube whose tip opens into wings (a mushroom or stellate head) so it stays in place in a cavity or tract. In current catalogues it is most often supplied as a Malecot nephrostomy catheter set, used by clinicians to drain the renal pelvis. This page covers how the design works, what a set contains, the sizes the manufacturers list, and what the instructions for use say about handling. It is written for clinic staff, buyers and students who need to identify the product class.
What a Malecot catheter is
A Malecot catheter is a self-retaining tube with a main shaft and a winged, mushroom-shaped distal end (Sonawane et al., 2019). It was originally described for suprapubic cystostomy and is used to drain fluids such as urine, bile or pus. Cook Medical’s instructions for use describe its Malecot nephrostomy set as intended for “nephrostomy drainage in the renal pelvis”.
Who uses it: it is a prescription device. Cook’s instructions state that US federal law restricts the device to sale by or on the order of a physician, and the published design study involved urologists.
How the wings and mushroom tip are built
The tube has three working parts: the main shaft, the stellate section (the wings) and the distal mushroom (Sonawane et al., 2019). Boston Scientific describes its multi-wing design as intended to provide secure placement for nephrostomy drainage. Cook’s set lists a flexible stylet supplied with the catheter, a retention disc with a pull tie, and a connecting tube.
Design history matters for identification. The original Malecot needed a needle and was hard to introduce into small fluid-filled spaces such as the renal pelvis. A flexible introduction system later allowed use in small spaces, and flexible stellate heads and dual-stiffness materials improved insertion and acceptance (Sonawane et al., 2019).
Types and variants
| Type | Typical use | Key difference | Source |
|---|---|---|---|
| Conventional Malecot | Nephrostomy drainage; originally suprapubic cystostomy | Main shaft, stellate wings and distal mushroom | Sonawane et al., 2019 |
| Malecot nephrostomy set (stylet-straightened wings) | Drainage of the renal pelvis through an existing nephrostomy tract | Supplied as a set with wire guide, dilators (optional), stylet, retention disc and connecting tube | Cook Medical IFU |
| Y-connector modified Malecot (14 F polyurethane) | Percutaneous nephrostomy | Proximal Y-connector: a central channel for the guidewire and an offset side channel for contrast, joined to a common 7.5 F channel, so contrast can be given without removing the wire | Sonawane et al., 2019 (small pilot study) |
The modified design was tested in a pilot of 5 modified and 5 conventional catheters rated by 5 urologists on a 5-point scale. Procedure time, fluoroscopy time and ease of insertion were comparable; ease of contrast study scored 2.2 for the conventional design and 4.4 for the modified one. The authors call it a small pilot needing multi-institutional validation, and the device was designed with a medical-device company. Treat it as a design variant, not an established standard.
Sizes and set contents
Boston Scientific lists two Malecot nephrostomy catheter sizes:
| Size | Length | Order number | UPN |
|---|---|---|---|
| 20 F | 35 cm | 410102 | M0064101020 |
| 24 F | 35 cm | 410103 | M0064101030 |
Boston Scientific states its set is compatible with a 0.038 in guidewire and contains no detectable latex. Cook notes that set components may vary, and the contents differ by manufacturer:
| Component | Cook Medical set | Boston Scientific set |
|---|---|---|
| Malecot catheter with stylet | Radiopaque catheter and flexible stylet | Two stylets (one for placement, one for post-procedure removal) |
| Wire guide | Included | 0.038 in PTFE guidewire |
| Dilators | Radiopaque dilators (optional) | 6 F to 16 F fascial dilators (even sizes) |
| Retention disc or cuff | Retention disc with pull tie | Percufix catheter cuff |
| Drainage connection | Connecting tube | Drainage bag connecting tube |
| Needles and scalpel | Not listed | 21 ga and 19 ga trocar point needles (the 19 ga with a 5 F PTFE sheath), #11 scalpel |
What the instructions for use say about handling
This is the part most buyers and storekeepers need. The table lines up what the manufacturer’s instructions and the US regulatory device record state.
| Topic | What the source states | Source |
|---|---|---|
| Use count | Intended for one-time use; single-use: yes | Cook IFU; AccessGUDID record |
| Sterility | Sterilized by ethylene oxide gas; peel-open package; sterile if the package is unopened and undamaged; do not use if sterility is in doubt | Cook IFU |
| Packaged sterile | Sterile packaged: yes; no sterilization needed before use (20 F Boston Scientific record) | AccessGUDID |
| Storage | Store in a dark, dry, cool place; avoid extended exposure to light | Cook IFU |
| Indwelling time | Should not exceed four weeks; evaluation and replacement beyond four weeks must be considered | Cook IFU |
| Contraindications and warnings | None known | Cook IFU |
| Classification | GMDN term 10735 “Nephrostomy catheter”; FDA product code GBW | AccessGUDID |
Cook also notes that the potential effects of phthalates on pregnant or nursing women and on children have not been fully characterized. Inspect the device for damage on removal from the package. Placement, removal and clinical decisions belong to the treating clinician following the manufacturer’s full instructions for use, which this page does not reproduce.
How to choose
The manufacturers label the product for nephrostomy drainage, and the two catalogue sizes above differ only in French size. A clinician selects the size and set on clinical grounds. A buyer can match the set contents to the component table above and to the manufacturer’s current instructions for use.
Common mistakes
- Leaving a device in beyond four weeks without evaluation: Cook’s instructions say the indwelling time should not exceed four weeks.
- Using a device from a damaged or opened package, or one whose sterility is in doubt.
- Treating a single-use device as reusable: Cook’s instructions say it is intended for one-time use.
- Assuming every set has the same parts: Cook states components may vary, and the Cook and Boston Scientific sets differ.
- Storing it in bright light: the instructions call for a dark, dry, cool place.
FAQ
What is a Malecot catheter?
A self-retaining drainage tube with a winged, mushroom-shaped distal end, used to drain fluids such as urine, bile or pus (Sonawane et al., 2019). Current catalogue sets are labelled for nephrostomy drainage.
What sizes does a Malecot nephrostomy catheter come in?
Boston Scientific lists 20 F and 24 F, both 35 cm long. Other manufacturers may list different sizes.
Is a Malecot catheter single-use?
Cook’s instructions say it is intended for one-time use, and the AccessGUDID record for the Boston Scientific 20 F device lists it as single-use.
How long can a Malecot nephrostomy catheter stay in?
Cook’s instructions say the indwelling time should not exceed four weeks, and that evaluation and replacement beyond four weeks must be considered. Decisions for an individual patient belong to the treating clinician.
Does a Malecot catheter need a prescription?
Cook’s instructions state that US federal law restricts the device to sale by or on the order of a physician, and the AccessGUDID record lists prescription use.
Related reading
For other drainage devices, see drainage catheter types and institutional stocking considerations, what a Foley catheter is, Foley versus suprapubic catheters and the urology clinic supply checklist. Product categories are listed under drainage catheters.
Sources
- Cook Medical, Instructions for Use, Malecot Nephrostomy Catheter Set (T_MNCS_REV1), https://ifu.cookmedical.com/data/IFU_PDF/T_MNCS_REV1.PDF, date checked 2026-10-30.
- Boston Scientific, Malecot Nephrostomy Catheter product page, https://www.bostonscientific.com/en-EU/products/pcnl/malecot-nephrostomy-catheter.html, date checked 2026-10-30.
- National Library of Medicine, AccessGUDID record for Malecot nephrostomy catheter system, 20 F, https://accessgudid.nlm.nih.gov/devices/08714729030997, date checked 2026-10-30.
- Sonawane P, Ganpule A, Sudharsan B, Singh A, Sabnis R, Desai M. Arab Journal of Urology 2019;17(4):330-334, doi:10.1080/2090598X.2019.1626587, https://pmc.ncbi.nlm.nih.gov/articles/PMC6830246/, date checked 2026-10-30.
