The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0624-2022·Announced 2022-02-23

Teleflex Arrow-Trerotola Percutaneous Thrombolytic Device PTD Kit recalled for tip separation

Teleflex recalls approximately 1,400 Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) kits due to reports of tip separation during use. The medical device is used for dialysis graft declotting and has been distributed worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls must be assigned a minimum severity score of 4. The hazard—catheter tip separation during use—involves a critical device failure mode in a life-sustaining medical application (dialysis vascular access).

Plain-English summary

Teleflex Medical Inc is recalling the Arrow-Trerotola Over-The-Wire PTD Kit, a percutaneous thrombolytic device used to mechanically declot arterio-venous (AV) fistulae and synthetic dialysis grafts. Approximately 1,400 units are affected.

The firm received reports indicating that the PTD catheter tip can separate during use, potentially compromising the device's intended function.

The recalled devices have been distributed worldwide, including throughout the United States and to 19 other 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. Multiple lot numbers are affected.

The recalled product

Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits…
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Dialysis / Vascular Access
Hazard
Affected units
1,400

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: 13F20A0323 / (01)108019022121292 (17)211231 (10)13F20A0323
  • Components: Code PT-65709-C
  • Lot number 13C19M0499
  • Code PT-65709-HFS
  • Lot number 14C19J0342
  • Code PT-03009
  • Lot number 13C19J1873
  • Lot number 13C19L0622
  • Lot number 13C19J0572
  • Lot number 13C19K0832
  • Lot Number / UDI: 13F20B0139 / (01)10801902121292 (17)220131 (10)13F20B0139
  • Lot number 13C20A0970
  • Lot number 14C20A0611
  • Lot number 14C19G0671
  • Lot Number / UDI: 13F20C0594 / (01)10801902121292 (17)220331 (10)13F20C0594
  • Lot number 13C20C2082
  • Lot number 13C20B1435
  • Lot Number / UDI: 13F20F008 3/ (01)10801902121292 (17)220531 (10)13F20F0083
  • Lot number 13C20F0572
  • Lot number 14C20D1060

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 →

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