The Recall Desk
SevereFDA (Devices)·Z-0627-2022·Announced 2022-02-23

Arrow-Trerotola Percutaneous Thrombolytic Device catheter tips may separate during use

The FDA is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters due to reports of tip separation during use. Approximately 3,668 units were distributed worldwide.

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 classified this as a Class I medical device recall, requiring a minimum severity score of 4. However, with no reported deaths, serious injuries, or hospitalizations documented in the source, the score is 4 rather than 5.

Plain-English summary

The FDA is recalling Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) sets, model PT-45509, manufactured by Teleflex Medical Inc. The PTD catheter works with the Arrow Rotator Drive Unit to mechanically remove blood clots from dialysis access sites, including native arterio-venous fistulae and synthetic grafts.

The firm reported instances in which the PTD catheter tip separated during use. A separated tip can compromise device function and affect patient safety during the declotting procedure.

Approximately 3,668 units were distributed worldwide, including the United States and multiple other countries. Specific affected lot numbers and device codes are provided in the FDA recall notice. Healthcare providers should identify affected devices in their inventories and discontinue their use.

The recalled product

Product
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native a
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Dialysis / Vascular Access
Hazard
Affected units
3,668

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: 13F20A0209 / (01)10801902121261(17)211231(10)13F20A0209
  • Components: Code PT-45509-S6
  • Lot number 14C19F1336
  • Code PT-45509-S6
  • Lot number 14C19J0340
  • Code PT-45509-T
  • Lot number 13C19L1173
  • Lot number 13C19M0193
  • Lot Number / UDI: 13F20B0054 / (01)10801902121261(17)220131(10)13F20B0054
  • Lot number 14C20A0602
  • Lot number 13C20A1583
  • Lot Number / UDI: 13F20B0527 / (01)10801902121261(17)220228(10)13F20B0527
  • Components: Code PT-45509-T
  • Lot number 13C20A2409
  • Lot Number / UDI: 13F20C0427 / (01)10801902121261(17)220228(10)13F20C0427
  • Lot number 13C20C0842
  • Lot Number / UDI: 13F20D0127 / (01)10801902121261(17)220331(10)13F20D0127
  • Lot number 14C20C1054
  • Lot number 13C20D0847
  • Lot Number / UDI: 13F20D0402 / (01)10801902121261(17)220430(10)13F20D0402

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 →

Related recalls

Same manufacturer · TELEFLEX MEDICAL INC

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