Nephrostomy Catheter System Kit Recalled Due to Sterile Barrier Defect
Boston Scientific is recalling Flexima Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier pouch that may compromise device sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a theoretical risk to device sterility. The source text does not report any illnesses or injuries. However, a compromised sterile barrier on an internal catheter system represents a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Boston Scientific Corporation is recalling the Flexima Regular Kit Nephrostomy Catheter System Kit (Material Number REF M001271860, Lot #33550953) used to provide external drainage of the urinary tract. The device is being recalled because the clear sterile barrier of the device pouch may have holes that could compromise the sterility of the catheter.
A compromised sterile barrier on a catheter system intended for internal use poses a risk of contamination. No illnesses or injuries related to this issue have been reported to date.
Affected devices were distributed in the United States, Colombia, Philippines, and Russia. The recalled kit contains 10 units with an expiration date of March 4, 2027. Healthcare facilities and patients who have received this product should contact Boston Scientific for instructions on whether their units are affected and what steps to take next.
The recalled product
- Product
- Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN/UDI 0871472932337
- Lot # 33550953
- exp. 03/04/2027
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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