CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) recalled
Boston Scientific is recalling Flexima APDL Drainage Catheter System and Kit, Material Numbers: a). The recall was initiated on 18 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3147-2024
- FDA event ID
- 95186
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jul 2024
- FDA classified
- 13 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 18 Jul 2024 | Recall initiated by company | |
| 13 Sep 2024 | Classified by FDA | +57 days |
| 25 Sep 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Where it was distributed
US, Colombia, Philippines, Russia
Questions about this recall
Why was it recalled?
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Which lots are affected?
a) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027
Where was it sold?
US, Colombia, Philippines, Russia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 95186This product is part of a recall event; the main page for the event is VTC Regular Kit Nephrostomy Catheter System Kit, Material Number recalled.
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