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 letter.
| 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.
On November 18, 2021, the U.S. Food and Drug Administration (FDA) classified the recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR as a Class I recall. FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Consumers who have affected product should immediately identify all patients that are currently exposed to use of this product, discontinue use, and return all affected product to Teleflex. The recall notice, with a list of affected product codes and lot numbers, can be found through the following link: https://teleflex.widen.net/s/mdr28xv2pr/fsn---eif-000484_us
Consumers with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday or email recalls@teleflex.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Original recall and updates at FDA