FDA Device recall Z-1483-2022
Medline Sprinter OTW, Model/Catalog Number SPR2512W
- FDA Device
- Class II
- ongoing
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class II recall of Medline Sprinter OTW, Model/Catalog Number SPR2512W by Medtronic, citing luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1483-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-24 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Reason
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Identifiers
| code_info | GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1483-2022%22
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