The Recall Desk
SevereFDA (Devices)·Z-0625-2022·Announced 2022-02-23

Arrow-Trerotola Dialysis Catheter Recalled for Tip Separation During Use

Arrow-Trerotola Over-The-Wire PTD catheters used in dialysis procedures are being recalled due to reports of tip separation during use. The FDA classified this as a Class I recall affecting 1,265 units 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 Class I classification applies to this recall, establishing a minimum severity of Severe. The product is a percutaneous thrombolytic catheter used in dialysis procedures; reports of tip separation during use indicate an actual device failure hazard.

Plain-English summary

Teleflex Medical Inc. is recalling the Arrow-Trerotola Over-The-Wire PTD Kit, a percutaneous thrombolytic device catheter used with the Arrow Rotator Drive Unit to mechanically declot native arterio-venous (AV) fistulae and synthetic dialysis grafts. The company received reports indicating that the PTD catheter tip can separate during use.

This is a Class I recall, meaning there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The recall affects 1,265 units distributed worldwide, including the US and 19 other countries. Multiple lot numbers are involved.

Patients and healthcare providers who use or have been implanted with these devices should contact their physician immediately. Facilities should quarantine affected lots and follow Teleflex's instructions for handling the recalled device. The specific lot numbers and component codes affected are listed in the original FDA notice.

The recalled product

Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of nati
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Dialysis / Vascular Access
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: 13F19M0129 / (01)10801902121315 (17)211130 (10)13F19M0129
  • Components: Code PT-65709-C
  • Lot number 13C19M0499
  • Lot Number / UDI: 13F20B0053 / (01)108019022121315 (17)220131 (10)13F20B0053
  • Lot number 13C20A0970
  • Lot Number / UDI: 13F20C0595 / (01)10801902121315 (17)220331 (10)13F20C0595
  • Lot number 13C20C2089
  • Code PT-65709-C
  • Lot number 13C20C2082
  • Lot Number / UDI: 13F20F0231 / (01)10801902121315 (17)220531 (10)13F20F0231
  • Components: Code PT-65709-C
  • Lot number 13C20F1139
  • Lot Number / UDI: 13F20G0361 / (01)10801902121315 (17)220731 (10)13F20G0361
  • Lot number 13C20G1199
  • Lot number 13C20G0228
  • Lot Number / UDI: 13F20K0632 / (01)10801902121315 (17)221031 (10)13F20K0632
  • Lot number 13C20H1675
  • Lot Number / UDI: 13F21A0353 / (01)10801902121315 (17)221231 (10)13F21A0353
  • Lot number 13C20M0639
  • Lot number 13C20J2689

Distribution

Distributed nationwide across the United States.

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