Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Abbott · Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead t…
Open FDA's page for this record- Cfres ID
- 213144
- Product res number
- Z-1644-2025
- Event date initiated
- 2025-03-17
- Event date posted
- 2025-04-21
- Recall status
- Open, Classified
- Res event number
- 96545
- Product code
- DQY
- Product description
- Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
- Firm FEI number
- 3005334138
- Recalling firm
- Abbott
- Address 1
- 5050 Nathan Ln N
- City
- Plymouth
- State
- MN
- Postal code
- 55442-3209
- Additional info contact
- Cynthia Kong 651-756-5400
- Root cause description
- Process control
- Product quantity
- 2683
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Code info
UDI-DI 00811806012926 Lots 9078966 9093895 9134623 9144113 9148110 9148579 9155868 9158302 9241591 9241593 10004059 10011461 10011462 10011463 10011465 10017790 10017792 10196106 10196119 10198795 10198801 10198889 10207472 10207503 10274454 10283818
- Reason for recall
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
- Action
On March 17, 2025, the firm notified customers via hand-delivered customer communications titled "Urgent Medical Device Recall." Customers were instructed to share the notice with applicable personnel and to return any remaining unused devices from impacted lots. Abbott representatives will assist with product return and replenishment. If you have any questions, please contact your local Sales Representative or Abbott Support at 1-800-544-1664.
- K numbers
- K162228
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Percutaneous
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1250
- Device class
- 2
- K number
- K934009, K122940, K101885, K240885, K182829, K212738, K852914, K953909, K052004, K120781, K250558, K903330, K810460, K192712, K033670, K894682, K252417, K090849, K051772, K232647, K101282, K023223, K130252, K070238, K072156, K070502, K082339, K181000, K123765, K033441, K871425, K884129, K060418, K853714, K032660, K132556, K861827, K031211, K001435, K943777 +856 more
- Registration number
- 3005255160, 3006950086, 2183744, 3008789872, 3010155661, 9681834, 2648729, 3007007790, 3009564766, 3007628272, 3009144177, 3004111573, 3010432890, 3031311812, 3015550451, 1450662, 9681260, 2020735, 3015225571, 1928237, 3000308637, 2521402, 3015309643, 1721676, 3038912532, 1313046, 8010026, 9681477, 3021951050, 3009888344, 3022392708, 3008573567, 3008361782, 3010273872, 3014687026, 3015053858, 3012154226, 3009380063, 9612164, 3020347218 +238 more
- FEI number
- 3005255160, 3002808904, 3006950086, 2183744, 3008789872, 3010155661, 3000206435, 2648729, 3007007790, 3009564766, 3007628272, 3009144177, 3004111573, 3010432890, 3002806500, 3031311812, 3015550451, 1450662, 2020735, 3015225571, 1928237, 3000308637, 2521402, 3015309643, 1721676, 3038912532, 1313046, 3021951050, 3009888344, 3022392708, 3008573567, 3008361782, 3008906816, 3010273872, 3014687026, 3015053858, 3012154226, 3009380063, 3020347218, 1000138054 +237 more