The Recall Desk
SevereFDA (Devices)·Z-0629-2022·Announced 2022-02-23

Arrow-Trerotola Percutaneous Thrombolytic Device Set Tip Separation Recall

Teleflex Medical Inc. is recalling Arrow-Trerotola PTD catheter sets due to reported tip separation during use. The device is used for mechanical declotting of vascular access fistulae and grafts.

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 severity score of 4. The defect involves mechanical failure (tip separation) of a critical vascular access device during clinical use, presenting potential risk to patients despite no injuries yet reported.

Plain-English summary

Teleflex Medical Inc. is recalling the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Set, REF PT-65509. This medical device, used with the Arrow Rotator Drive Unit, performs mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

The recall is due to reports indicating that the PTD catheter tip can separate during use. This mechanical failure could compromise device function during vascular access procedures.

Approximately 14,583 units are affected across 48 identified lot numbers, with expiration dates ranging from December 2021 through October 2023. The devices have been distributed worldwide, including throughout the United States and to 19 additional countries: Australia, Belgium, Canada, Chile, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, South Korea, Kuwait, Netherlands, Panama, Philippines, Portugal, Saudi Arabia, and Turkey.

Healthcare facilities should verify whether they have affected devices by checking device lot numbers against the recall list provided by the FDA. Teleflex Medical Inc. is coordinating replacement and return procedures for affected units.

The recalled product

Product
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fist
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Vascular Access Catheter
Hazard
  • tip-separation
  • mechanical-failure

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: 13F20A0286 / (01)00801902013156(17)211231(10)13F20A0286
  • Lot Number / UDI: 13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426
  • Lot Number / UDI: 13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640
  • Lot Number / UDI: 13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141
  • Lot Number / UDI: 13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276
  • Lot Number / UDI: 13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353
  • Lot Number / UDI: 13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424
  • Lot Number / UDI: 13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352
  • Lot Number / UDI: 13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425
  • Lot Number / UDI: 13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426
  • Lot Number / UDI: 13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122
  • Lot Number / UDI: 13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123
  • Lot Number / UDI: 13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124
  • Lot Number / UDI: 13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403
  • Lot Number / UDI: 13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204
  • Lot Number / UDI: 13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232
  • Lot Number / UDI: 13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389
  • Lot Number / UDI: 13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353
  • Lot Number / UDI: 13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729
  • Lot Number / UDI: 13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378

Distribution

Distributed nationwide across the United States.

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