CLASS I ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
Obsidio Conformable Embolic, Material Numbers (UPN) recalled
Boston Scientific is recalling Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010. The recall was initiated on 20 Feb 2024 and the FDA has classified it as Class I.
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-1374-2024
- FDA event ID
- 94126
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Feb 2024
- FDA classified
- 27 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Feb 2024 | Recall initiated by company | |
| 27 Mar 2024 | Classified by FDA | +36 days |
| 3 Apr 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Where it was distributed
US
Questions about this recall
Is Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 recalled?
Yes. Boston Scientific recalled Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 on 20 Feb 2024. The recall is Class I and its status is Ongoing. Recall number Z-1374-2024.
Why was it recalled?
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.
Which lots are affected?
a) M0013972001010, UDI/DI 00191506039332, ALL LOT CODES b) M0013972101010, UDI/DI 00191506043124, ALL LOT CODES
Where was it sold?
US
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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