Arrow-Trerotola Percutaneous Thrombolytic Device Inner Lumen Detachment Recall
The inner lumen of Arrow-Trerotola Over-The-Wire PTD catheters (7FR) can detach from the device, causing an embolism. This requires additional medical intervention and delays treatment.
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, which establishes a minimum severity score of 4. The device defect can cause embolization, a serious medical complication requiring additional intervention. While no deaths or reported serious injuries are explicitly stated in the source, the nature of the defect and its potential consequences justify a Severe classification.
Plain-English summary
The Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device (PTD) Kit, 7FR size, is being recalled by Arrow International Inc. This device is used to mechanically clear blood clots from dialysis grafts and fistulas. The recall affects 447 units distributed worldwide, including throughout the United States and to multiple countries internationally.
The defect involves the device's inner lumen (orange component), which can detach from the device basket. When detachment occurs, the separated piece can enter the bloodstream, causing embolization (the traveling of foreign material through blood vessels). This complication requires additional medical intervention to retrieve the detached piece and results in a delay of the patient's treatment.
The recall affects devices with the following lot numbers: 13F19K0564, 13F20C0094, 13F20G0284, 13F20L0282, 13F21A0497, 13F21A0718, 13X21E0008, and 13F21F1187. Healthcare providers using these devices should cease use of affected lots immediately and contact Arrow International Inc for guidance on device return and replacement options.
The recalled product
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native…
- Manufacturer
- Arrow International Inc
- Affected units
- 447
Distribution
Part of a larger recall action
This product is one of 4 recalled by Arrow International 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 4 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
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