FDA Medical Device Recalls (openFDA)
TELEFLEX MEDICAL INC: Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Recall number
- Z-0629-2022
- Recalling firm
- TELEFLEX MEDICAL INC
- Product
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Status
- Terminated
- Initiated
- 2022-01-11
- Posted
- 2022-02-15
- Terminated
- 2024-09-11
- Reason
- The firm received reports indicating PTD tip separation during use.
- Root cause
- Process change control
- Action
- Arrow International LLC/Teleflex notified their consignees by letter on 01/11/2022. The letter explained the issue and requested that the consignee cease use and distribution. Distributors were directed to notify their customers. The firm is seeking return of the affected product. The following instructions were provided: Action list number 1 Medical facilities 1. We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-mail address mentioned below. 3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1) and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Action list number 2 Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the Acknowledgement Form and return to you. 2. We request that you check your inventory for product within the scope of this FSCA. Cease use and distribution of impacted product and quarantine immediately. You may then return all product in scope to Teleflex. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined above. Upon completion of your actions, please forward the completed Acknowledgement Form to Customer Service. Important - Please ensure you only list batch numbers in scope of this Field Safety Notice when completing this form. 4. If you have further distr
- Quantity
- 14583 units
- Distribution
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- Lot, serial or model codes
- Lot Number / UDI: 13F20A0286 / (01)00801902013156(17)211231(10)13F20A0286; Lot Number / UDI: 13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426; Lot Number / UDI: 13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640; Lot Number / UDI: 13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141; Lot Number / UDI: 13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276; Lot Number / UDI: 13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353; Lot Number / UDI: 13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424; Lot Number / UDI: 13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352; Lot Number / UDI: 13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425; Lot Number / UDI: 13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426; Lot Number / UDI: 13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122; Lot Number / UDI: 13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123; Lot Number / UDI: 13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124; Lot Number / UDI: 13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403; Lot Number / UDI: 13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204; Lot Number / UDI: 13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232; Lot Number / UDI: 13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389; Lot Number / UDI: 13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353; Lot Number / UDI: 13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729; Lot Number / UDI: 13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378; Lot Number / UDI: 13F20J0546 / (01)00801902013156(17)220831(10)13F20J0546; Lot Number / UDI: 13F20J0771 / (01)00801902013156(17)220831(10)13F20J0771; Lot Number / UDI: 13F20K0503 / (01)00801902013156(17)220930(10)13F20K0503; Lot Number / UDI: 13F20K0504 / (01)00801902013156(17)220930(10)13F20K0504; Lot Number / UDI: 13F20K0630 / (01)00801902013156(17)220930(10)13F20K0630; Lot Number / UDI: 13F20K0631 / (01)00801902013156(17)220930(10)13F20K0631; Lot Number / UDI: 13F20M0175 / (01)00801902013156(17)221130(10)13F20M0175; Lot Number / UDI: 13F20M0176 / (01)00801902013156(17)221130(10)13F20M0176; Lot Number / UDI: 13F20M0177 / (01)00801902013156(17)221130(10)13F20M0177; Lot Number / UDI: 13F20M0178 / (01)10801902013153(17)221130(10)13F20M0178; Lot Number / UDI: 13F20M0181 / (01)00801902013156(17)221231(10)13F20M0181; Lot Number / UDI: 13F21A0352 / (01)00801902013156(17)221231(10)13F21A0352; Lot Number / UDI: 13F21B0159 / (01)00801902013156(17)230131(10)13F21B0159; Lot Number / UDI: 13F21B0222 / (01)00801902013156(17)230131(10)13F21B0222; Lot Number / UDI: 13F21B0519 / (01)10801902013153(17)230228(10)13F21B0519; Lot Number / UDI: 13F21C0364 / (01)00801902013156(17)230228(10)13F21C0364; Lot Number / UDI: 13F21C0365 / (01)00801902013156(17)230228(10)13F21C0365; Lot Number / UDI: 13F21D0462 / (01)00801902013156(17)230331(10)13F21D0462; Lot Number / UDI: 13F21E0079 / (01)00801902013156(17)230430(10)13F21E0079; Lot Number / UDI: 13F21E0259 / (01)00801902013156(17)230430(10)13F21E0259; Lot Number / UDI: 13F21E0260 / (01)00801902013156(17)230430(10)13F21E0260; Lot Number / UDI: 13F21E0556 / (01)00801902013156(17)230430(10)13F21E0556; Lot Number / UDI: 13F21F0641 / (01)00801902013156(17)230531(10)13F21F0641; Lot Number / UDI: 13F21G0227 / (01)00801902013156(17)230630(10)13F21G0227; Lot Number / UDI: 13F21G0401 / (01)00801902013156(17)230630(10)13F21G0401; Lot Number / UDI: 13F21G0772 / (01)00801902013156(17)230630(10)13F21G0772; Lot Number / UDI: 13F21H0447 / (01)10801902194074(17)230731(10)13F21H0447; Lot Number / UDI: 13F21K0827 / (01)10801902194074(17)231031(10)13F21K0827; Lot Number / UDI: 13F21K0898 / (01)10801902194074(17)231031(10)13F21K0898; Lot Number / UDI: 13F21L0227 / (01)20801902194071(17)231031(10)13F21L0227; Lot Number / UDI: 13F21L0507 / (01)10801902194074(17)231031(10)13F21L0507; Lot Number / UDI: 13F21L0898 / (01)10801902194074(17)231031(10)13F21L0898
- 510(k) numbers
- ["K011056"]
- PMA numbers
- not on file
- Product code
- QEW
- Firm FEI
- 3005747797
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28