Drug recall
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
FDA recall event 94126 · Class I · Boston Scientific Corporation
Key facts
| Event ID | 94126 |
|---|---|
| Recall numbers | Z-1374-2024 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 20, 2024 |
| Report date | Apr 3, 2024 |
| City | Maple Grove |
| State | MN |
| Country | United States |
| FEI number | 3002095335 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: