The Recall Desk
SevereFDA (Devices)·Z-0628-2022·Announced 2022-02-23

Arrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use

Teleflex Medical is recalling 5,530 Arrow-Trerotola PTD catheter kits due to reports of tip separation during use. The hazard could prevent the device from functioning properly to remove blood clots from dialysis access 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: This is a Class I medical device recall per FDA classification, indicating serious potential for adverse health consequences. The hazard of tip separation during use of a critical vascular access device poses significant risk, though no adverse events are reported in the recall notice.

Plain-English summary

Teleflex Medical Inc. is recalling 5,530 units of the Arrow-Trerotola PTD Kit (Percutaneous Thrombolytic Device), model 5 Fr. X 65 cm, REF PT-65509-HFC. The kits have been distributed worldwide, including throughout the United States and in Australia, Belgium, Canada, Chile, Czech Republic, Germany, Spain, France, Great Britain, Israel, Italy, South Korea, Kuwait, Netherlands, Panama, Philippines, Portugal, Saudi Arabia, and Turkey.

The firm received reports indicating that the PTD catheter tip can separate from the device during use. The PTD is designed to work with the Arrow Rotator Drive Unit to mechanically remove blood clots from native arterio-venous fistulae and synthetic dialysis grafts—critical vascular access devices used in dialysis treatment. Tip separation could impede the procedure and potentially cause vascular complications.

Healthcare providers and patients who use or have been treated with these devices should check their inventory against the affected lot numbers provided in the FDA recall notice and discontinue use of any recalled kits immediately.

Those with concerns or who have experienced problems with the recalled device should contact Teleflex Medical Inc. or report the incident to the FDA.

The recalled product

Product
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Vascular Access Device
Hazard
  • tip-separation
  • device-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: 13F20A0359 / (01)10801902121285(17)211231(10)13F20A0359
  • Components: Code PT-65509-S
  • Lot number 14C19H0644
  • Code PT-65509-S
  • Lot number 14C19L1402
  • Code PT-03000
  • Lot number 13C19J0203
  • Code PT-01000-D
  • Lot number 13C19L2034
  • Lot Number / UDI: 13F20A0519 / (01)10801902121285(17)211131(10)13F20A0519
  • Lot number 13C19M0279
  • Lot number 13C20A0986
  • Lot Number / UDI: 13F20B0140 / (01)10801902121285(17)220131(10)13F20B0140
  • Lot number 13C19M0954
  • Lot number 13C20A2408
  • Lot Number / UDI: 13F20B0423 / (01)10801902121285(17)220228(10)13F20B0423
  • Lot number 13C20A0627
  • Lot number 13C20B1758
  • Lot Number / UDI: 13F20C0223 / (01)10801902121285(17)220228(10)13F20C0223
  • Lot number 13C20B2334

Distribution

Distributed nationwide across the United States.

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