Summary
- Company Announcement Date:
- November 26, 2021
- FDA Publish Date:
- November 30, 2021
- Product Type:
- Medical Devices
- Reason for Announcement:
-
Inner lumen may detach from the device’s basket
- Company Name:
- Teleflex Incorporated
- Brand Name:
-
Arrow
- Product Description:
-
Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR
Company Announcement
WAYNE, Pa., Nov. 26, 2021 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR. The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The products involved in the recall are as follows. Additional detail about how to identify the affected products is available in the recall letterExternal Link Disclaimer.
Product Code | Lot Number | Unique Device Identifier (UDI) # |
---|---|---|
PT-12709-WC | 13F19K0564 | (01)20801902156758 (17)210930 (10)13F19K0564 |
13F20C0094 | (01)10801902121254 (17)220228 (10)13F20C0094 | |
13F20G0284 | (01)10801902121254 (17)220630 (10)13F20G0284 | |
13F20L0282 | (01)10801902121254 (17)221031 (10)13F20L0282 | |
13F21A0497 | (01)10801902121254 (17)221231 (10)13F21A0497 | |
13F21A0718 | (01)10801902121254 (17)230131 (10)13F21A0718 | |
13F21F1187 | (01)10801902121254 (17)230630 (10)13F21F1187 | |
13X21E0008 | (01)10801902121254 (17)230531 (10)13X21E0008 | |
PT-65709-HFWC | 13F19K0369 | (01)10801902121292 (17)210930 (10)13F19K0369 |
13F20A0323 | 01)108019022121292 (17)211231 (10)13F20A0323 | |
13F20B0139 | (01)10801902121292 (17)220131 (10)13F20B0139 | |
13F20C0594 | (01)10801902121292 (17)220331 (10)13F20C0594 | |
13F20F0083 | (01)10801902121292 (17)220531 (10)13F20F0083 | |
13F20F0230 | (01)10801902121292 (17)220531 (10)13F20F0230 | |
13F20F0577 | (01)10801902121292 (17)220630 (10)13F20F0577 | |
13F20H0756 | (01)10801902121292 (17)220831 (10)13F20H0756 | |
13F20K0849 | (01)10801902121292 (17)221031 (10)13F20K0849 | |
13F20L0283 | (01)10801902121292 (17)221031 (10)13F20L0283 | |
13F20M0182 | (01)10801902121292 (17)221231 (10)13F20M0182 | |
13F21A0498 | (01)10801902121292 (17)221231 (10)13F21A0498 | |
13F21B0158 | (01)10801902121292 (17)230131 (10)13F21B0158 | |
13F21C0747 | (01)10801902121292 (17)230331 (10)13F21C0747 | |
13F21E0555 | (01)108019021212292 (17)230430 (10)13F21E0555 | |
PT-65709-W | 13F19M0129 | (01)10801902121315 (17)211130 (10)13F19M0129 |
13F20B0053 | (01)108019022121315 (17)220131 (10)13F20B0053 | |
13F20C0595 | (01)10801902121315 (17)220331 (10)13F20C0595 | |
13F20F0231 | (01)10801902121315 (17)220531 (10)13F20F0231 | |
13F20G0361 | (01)10801902121315 (17)220731 (10)13F20G0361 | |
13F20K0632 | (01)10801902121315 (17)221031 (10)13F20K0632 | |
13F21A0353 | (01)10801902121315 (17)221231 (10)13F21A0353 | |
13F21C0748 | (01)10801902121315 (17)230331 (10)13F21C0748 | |
13F21D0721 | (01)10801902121315 (17)230430 (10)13F21D0721 | |
13F21E0823 | (01)10801902121315 (17)230531 (10)13F21E0823 | |
13F21F1189 | (01)10801902121315 (17)230630 (01)13F21F1189 | |
PT-65709-WC | 13F19J0656 | (01)20801902156741 (17)210930 (10)13F19J0656 |
13F19K0342 | (01)20801902156741 (17)210930 (10)13F19K0342 | |
13F19K0368 | (01)10801902121308 (17)210930 (10)13F19K0368 | |
13F20C0596 | (01)10801902121308 (17)220331 (10)13F20C0596 | |
13F20F0081 | (01)10801902121308 (17)220531 (10)13F20F0081 | |
13F20F0229 | (01)10801902121308 (17)220531 (10)13F20F0229 | |
13F20F0509 | (01)10801902121308 (17)220531 (10)13F20F0509 | |
13F20F0578 | (01)10801902121308 (17)220630 (10)13F20F0578 | |
13F20G0177 | (01)10801902121308 (17)220630 (10)13F20G0177 | |
13F20G0566 | (01)10801902121308 (17)220630 (10)13F20G0566 | |
13F20H0531 | (01)10801902121308 (17)220831 (10)13F20H0531 | |
13F20J0379 | (01)10801902121308 (17)220831 (10)13F20J0379 | |
13F20L0514 | (01)10801902121308 (17)221031 (10)13F20L0514 | |
13F21A0354 | (01)10801902121308 (17)221231 (10)13F21A0354 | |
13F21C0081 | (01)10801902121308 (17)230228 (10)13F21C0081 | |
13F21C0749 | (01)10801902121308 (17)230331 (10)13F21C0749 | |
13F21D0870 | (01)10801902121308 (17)230430 (10)13F21D0870 | |
13F21E0415 | (01)10801902121308 (17)230430 (10)13F21E0415 | |
13F21F1188 | (01)10801902121308 (17)230630 (10)13F21F1188 |
Teleflex initiated this voluntary Field Safety Corrective Action on September 20, 2021 due to reports received indicating that the PTD’s Inner lumen (orange) detached from the device’s basket. Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR manufactured from October 2019 through July 2021 are subject to the recall.
If the orange inner lumen detaches from the basket, health consequences depend upon whether, and where, the fractured tip component embolizes. In most cases, the embolization is local to the treatment target site, allowing retrieval with an additional intervention and consequent delay of therapy. In some cases, the embolization could be central or peripheral and result in, or threaten to cause, local ischemia. Such an occurrence could require a more complex catheter-based intervention for retrieval, or rarely, surgical retrieval. The lumen component is radio-opaque.
As of November 2021, a total of seven customer complaints have been received for this issue. In one complaint, a snare was used by the clinician to retrieve the detached lumen from the patient. No long-term patient complications have been reported.
Read the full report here.
As published on Healthyexaminer.com.