The Recall Desk
SevereFDA (Devices)·Z-0626-2022·Announced 2022-02-23

Arrow-Trerotola Percutaneous Thrombolytic Device Kits Recalled for Tip Separation

Teleflex is recalling Arrow-Trerotola Percutaneous Thrombolytic Device kits worldwide due to reports of tip separation during use, affecting approximately 1,874 units.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification indicates serious potential for adverse health consequences. Device tip separation during use has been documented, but no illnesses or injuries are reported in the source.

Plain-English summary

Teleflex Medical Inc. is recalling Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device (PTD) kits worldwide due to reports of tip separation during use. The PTD Catheter is designed to work with the Arrow Rotator Drive Unit to mechanically declot native arterio-venous fistulae and synthetic dialysis grafts in patients on dialysis.

Approximately 1,874 units have been distributed worldwide, including throughout the United States and to multiple countries. Multiple lot numbers are affected.

Healthcare providers and patients with the affected product should stop use and contact Teleflex Medical Inc. for return instructions. Patients who have received this device should notify their healthcare provider.

The recalled product

Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits me
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Dialysis / Thrombolytic Device
Hazard
Affected units
1,874

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Number / UDI: 13F20C0596 / (01)10801902121308 (17)220331 (10)13F20C0596
  • Components: Code PT-65709-C
  • Lot number 13C20C2082
  • Code PT-65709-HS
  • Lot number 14C20C1417
  • Code PT-03009
  • Lot number 13C20B1435
  • Lot number 13C19M0278
  • Lot number 13C19L0622
  • Lot number 13C20C1558
  • Lot Number / UDI: 13F20F0081 / (01)10801902121308 (17)220531 (10)13F20F0081
  • Lot number 13C20F0572
  • Code PT-65709-C
  • Lot number 14C20C0866
  • Lot number 14C19K1035
  • Lot Number / UDI: 13F20F0229 / (01)10801902121308 (17)220531 (10)13F20F0229
  • Lot number 13C20F0570
  • Lot Number / UDI: 13F20F0509 / (01)10801902121308 (17)220531 (10)13F20F0509
  • Lot number 13C20F1139
  • Lot Number / UDI: 13F20F0578 / (01)10801902121308 (17)220630 (10)13F20F0578

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 7 recalled by TELEFLEX MEDICAL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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Same hazard · component separation

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