FDA Device recall Z-3144-2026
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS)
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS) by Maquet Cardiopulmonary, citing the packaging may not consistently maintain sterile barrier integrity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3144-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-31 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Maquet Cardiopulmonary |
| Distribution | US |
Product
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Reason
The packaging may not consistently maintain sterile barrier integrity.
Identifiers
| code_info | Model Number (USA): 701053068; UDI-DI: 4037691519883; Lot Numbers: 3000324477, 3000333824, 3000336037, 3000341450, 3000…Model Number (USA): 701053068; UDI-DI: 4037691519883; Lot Numbers: 3000324477, 3000333824, 3000336037, 3000341450, 3000343893, 3000377475, 3000387891, 3000403656, 3000414516, 3000430803, 3000441821, 3000453326, 3000471523, 3000476321, 3000485151, 3000496204, 3000510428, 3000518006, 3000554731; Model Number (OUS): 701047384; UDI-DI: 4037691730660; Lot Numbers: 3000324479, 3000324480, 3000328829, 3000328830, 3000328831, 3000331203, 3000331204, 3000331206, 3000331224, 3000333819, 3000333820, 3000334780, 3000334781, 3000334782, 3000336034, 3000336035, 3000338097, 3000338098, 3000339838, 3000339839, 3000341457, 3000341458, 3000342412, 3000342413, 3000343902, 3000343903, 3000347872, 3000347873, 3000349433, 3000350472, 3000350473, 3000350474, 3000351949, 3000351950, 3000353375, 3000354955, 3000354956, 3000354957, 3000356333, 3000356334, 3000356335, 3000357761, 3000357762, 3000359475, 3000364061, 3000364062, 3000369310, 3000369312, 3000369316, 3000372382, 3000372383, 3000373778, 3000373779, 3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Maquet Cardiopulmonary
- Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS)
FDA Device · Class II · 2026-09-23 · Maquet Cardiopulmonary - Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS)
FDA Device · Class II · 2026-09-23 · Maquet Cardiopulmonary - Bubble Sensor for 3/8" x 3/32" tubing
FDA Device · Class II · 2026-02-11 · Maquet Cardiopulmonary - Sprinter Cart/Sprinter Cart XL Infusion Pole
FDA Device · Class II · 2025-08-06 · Maquet Cardiopulmonary
All Maquet Cardiopulmonary recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3144-2026%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.