The Recall Desk
SevereFDA (Devices)·Z-0623-2022·Announced 2022-02-23

Arrow-Trerotola Thrombolytic Device Tip Separation During Use Recalled

Teleflex Medical is recalling Arrow-Trerotola PTD kits due to reports of tip separation during use. The affected device is used for declotting dialysis grafts and fistulae.

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 mandates a minimum score of 4. Tip separation during use of a vascular catheter used for dialysis access represents serious potential for clinical harm, even absent reported injuries to date.

Plain-English summary

Teleflex Medical Inc. is recalling the Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device (PTD) Kit. The company received reports indicating that the PTD tip can separate during use. This device is used in conjunction with the Arrow Rotator Drive Unit to mechanically declot native arterio-venous fistulae and synthetic dialysis grafts.

The recall affects 676 units with worldwide distribution, including throughout the United States and to Australia, Belgium, Canada, Chile, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, South Korea, Kuwait, Netherlands, Panama, Philippines, Portugal, Saudi Arabia, and Turkey. Multiple lot numbers are involved, with specific component codes and expiration dates documented.

Healthcare facilities and providers should immediately discontinue use of affected kits and contact Teleflex Medical Inc. for information regarding returns and replacements. Patients who may have received treatment with this device should consult their healthcare provider about their specific situation.

Tip separation during use represents a device malfunction that could impair the device's intended function and pose risks during the declotting procedure.

The recalled product

Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Vascular Catheter
Hazard
  • tip-separation
  • device-malfunction

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: 13F19K0564 / (01)20801902156758 (17)210930 (10)13F19K0564
  • Components: Code PT-12709-CA
  • Lot number 13C19K2024
  • Code PT-65709-HS
  • Lot number 14C19K1035
  • Code PT-03009
  • Lot number 13C19J1873
  • Lot Number / UDI: 13F20C0094 / (01)10801902121254 (17)220228 (10)13F20C0094
  • Components: Code PT-12709-C
  • Lot number 13C20C0498
  • Lot number 13C19L0622
  • Lot number 13C19M0278
  • Lot Number / UDI: 13F20G0284 / (01)10801902121254 (17)220630 (10)13F20G0284
  • Lot number 13C20G0230
  • Lot number 14C20D1061
  • Lot number 13C20G0238
  • Lot number 13C20F2585
  • Lot Number / UDI: 13F20L0282 / (01)10801902121254 (17)221031 (10)13F20L0282
  • Lot number 13C20J0307
  • Lot number 14C20H0384

Distribution

Distributed nationwide across the United States.

Related recalls

Same category