Reported Aug 25, 2021 · Ongoing
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
- Lot codes and dates
- GTIN 05060116920635
- Lot Numbers
616736986167369961673700616737026169412461705932617066566170593361732176
- Amount recalled
- 4200 sets
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential for leaks and loosening at the patient catheter connection
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.