Cope recallZ-1829-2022 · Cook Incorporated · initiated Aug 16, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
FDA root cause category: Under Investigation by firm
What the company is doing
On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Recall details
- Recall number
- Z-1829-2022
- Status
- Open, Classified
- Initiated by the company
- Aug 16, 2022
- Posted by the FDA
- Sep 28, 2022
- Recalling firm
- Cook Incorporated
- Quantity
- 1,501 US; 380 OUS
- Product code
- DQX
- FDA submissions
- K171997
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
Product description
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
PMG-18SP-60-COPE-NT-ST G09395 UDI-DI: 00827002093959 Lot/Expiration Date 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027 PMG-18SP-100-COPE-NT G08687 UDI-DI: 00827002086876 Lot/Expiration Date 14811839 24-06-2027 14839563 13-07-2027 PMG-18SP-60-COPE-NT G08427 UDI-DI: 00827002084278 Lot/Expiration Date 14816750 28-06-2027 14816753 28-06-2027 14816754 28-06-2027 14816755 28-06-2027 14816757 28-06-2027 14821755 30-06-2027 14821756 30-06-2027 14821758 30-06-2027 14831332 07-07-2027 14831333 07-07-2027 14831335 07-07-2027 14831336 07-07-2027 NS14813725 27-06-2027 NS14816751 28-06-2027 NS14821760 30-06-2027 NS14828069 05-07-2027 14809498 23-06-2027 14809499 23-06-2027 14811841 24-06-2027
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cope G08427Cook Incorporated · WIRE, GUIDE, CATHETER1 recall23 reports
- Cope G08687Cook Incorporated · WIRE, GUIDE, CATHETER1 recall1 report
- Cope G09395Cook Incorporated · WIRE, GUIDE, CATHETER1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90793).
- Z-1824-2022 · Open, ClassifiedAmplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
- Z-1825-2022 · Open, ClassifiedBentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
- Z-1826-2022 · Open, ClassifiedBentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
- Z-1827-2022 · Open, ClassifiedBentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
- Z-1828-2022 · Open, ClassifiedCoons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
- Z-1830-2022 · Open, ClassifiedCope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
- Z-1831-2022 · Open, ClassifiedDouble Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 …
- Z-1832-2022 · Open, ClassifiedFixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
- Z-1833-2022 · Open, ClassifiedFixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00…
- Z-1834-2022 · Open, ClassifiedFixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 T…
- Z-1835-2022 · Open, ClassifiedHeavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
- Z-1836-2022 · Open, ClassifiedNewton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
- Z-1837-2022 · Open, ClassifiedRoadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-03814…
- Z-1838-2022 · Open, ClassifiedRoadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
- Z-1839-2022 · Open, ClassifiedRoadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
- Z-1840-2022 · Open, ClassifiedRoadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
- Z-1841-2022 · Open, ClassifiedRoadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
- Z-1842-2022 · Open, ClassifiedRosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
- Z-1843-2022 · Open, ClassifiedTorq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
- Z-1844-2022 · Open, ClassifiedVinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
- Z-1845-2022 · Open, ClassifiedLunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
- Z-1846-2022 · Open, ClassifiedMovable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
- Z-1847-2022 · Open, ClassifiedMovable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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