NewtonRecalls & reported problems across all models
Cook Incorporated · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Newton model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of Newton by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2024 and Jun 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Newton recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 16, 2022Open, Classified
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.
Z-1836-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Newton problems
Device problems
- Unraveled Material2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Newton models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Newton G00561WIRE, GUIDE, CATHETER1 recall0 reports
- Newton G00701WIRE, GUIDE, CATHETER1 recall0 reports
- Newton G00715WIRE, GUIDE, CATHETER1 report
- Newton G00794WIRE, GUIDE, CATHETER1 report
Recent Newton adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Unraveled Material; Unraveled Material
AS REPORTED, UPON OPENING THE DEVICE PACKAGE, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, APPROXIMATELY FIVE CENTIMETERS OF A NEWTON STRAIGHT FIXED CORE WIRE GUIDE¿S DISTAL TIP WAS FOUND TO BE ELONGATED, STRETCHED, AND ¿VERY FLOPPY¿. PER THE REPORTER, THE DEVICE WAS DAMAGED PRIOR TO OPENING THE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22322739 ↗MalfunctionJun 11, 2024Break; Unraveled Material; Break; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19514992 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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