Boston Scientific Recalls Flexima APDL Drainage Catheter Systems Due to Sterility Risk
Boston Scientific is recalling 89 units of Flexima APDL Drainage Catheter Systems because holes in the sterile barrier 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: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling 89 units of the Flexima APDL Drainage Catheter System and Kit. The recall involves two specific material numbers: REF M001271960 (Lot # 33540319, Exp. 03/01/2027) and REF M001271970 (Lot # 33471466, Exp. 02/21/2027). The affected devices are all-purpose drainage catheters with locking pigtails.
The recall was initiated because there is a potential for holes in the clear sterile barrier of the device pouch. This defect may impact the sterility of the device, posing a risk to patients who use the catheter.
The affected units were distributed in the United States, Colombia, the Philippines, and Russia. Healthcare providers and patients should stop using the affected devices and contact Boston Scientific Corporation for further instructions on replacement or return.
The recalled product
- Product
- Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 89
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 (6)
- a) GTIN/UDI 0871472932347
- Lot # 33540319
- Exp. 03/01/2027
- b) GTIN/UDI 0871472932348
- Lot # 33471466
- Exp. 02/21/2027
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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