FDA Device recall Z-1329-2021
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads a…
- FDA Device
- Class II
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads a… by Oscor, citing potential for open seal on sterile product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1329-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-10 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Oscor |
| Distribution | US |
Product
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Reason
Potential for open seal on sterile product
Identifiers
| code_info | GUDID: 25051684026298; Lot Number DP-11759 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Oscor
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acces…
FDA Device · Class I · 2026-07-22 · Oscor - Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
FDA Device · Class I · 2026-07-22 · Oscor - Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and…
FDA Device · Class I · 2026-07-22 · Oscor - Destino Twist 14F (also branded as Guidestar 14F)
FDA Device · Class II · 2022-02-23 · Oscor - TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart
FDA Device · Class I · 2018-11-14 · Oscor
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1329-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.