SOLO PLUS Stiff Hybrid Guidewires HW35SARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816840020319), received between Jul 6, 2023 and Aug 8, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Missing Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT PACKAGING SAID TWO CASES OF SOLO PLUS HYBRID GUIDEWIRE WAS SHIPPED BUT WHAT ARRIVED HAD NO CATALOG NUMBER, LOT CODE, EXPIRATION DATE OR ANY IDENTIFIABLE INFORMATION TW# (B)(4) AND PACKAGING BOX WAS BLANK AND SO WAS THE PRODUCT WRAPPING TW# (B)(4). THEY BELIEVED THIS MIGHT BE A MIS-PICK OR SHORT-SHIPPED ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484322 ↗
• MalfunctionJul 6, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT THE STENT (MATERIAL #778726- PR# (B)(4)) AND GUIDEWIRE (MATERIAL # HW35SA- PR# (B)(4) ) HAD NO INFORMATION ON BOX OR PRODUCT INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17274159 ↗