CORDIS 598943PRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20705032019092), received between Nov 27, 2018 and Jul 16, 2021 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (23 reports).

1 other recall cover devices cleared under the same FDA submission (K992673); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, SEVENTY-THREE (73) BOXES OF .098¿ 9F 55CM VISTA BRITE TIP STRAIGHT (STR) GUIDING CATHETER HAD PARTICULATE MATTER MINUTE CARDBOARD SHAVINGS, FOUND INSIDE ITS STERILE POUCH. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. IT WAS DETECTED IN THE WAREHOUSE AND THE DEVICES NEVER MADE IT TO A HOSPITAL. THE ACTUAL PRODUCT WAS NOT DAMAGED. TOTAL OF SIX (6) DEVICES WILL BE RETURNED (2 FROM EACH LOT) WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180936 ↗
• MalfunctionJul 16, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, SEVENTY-THREE (73) BOXES OF .098¿ 9F 55CM VISTA BRITE TIP STRAIGHT (STR) GUIDING CATHETER HAD PARTICULATE MATTER MINUTE CARDBOARD SHAVINGS, FOUND INSIDE ITS STERILE POUCH. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. IT WAS DETECTED IN THE WAREHOUSE AND THE DEVICES NEVER MADE IT TO A HOSPITAL. THE ACTUAL PRODUCT WAS NOT DAMAGED. TOTAL OF SIX (6) DEVICES WILL BE RETURNED (2 FROM EACH LOT) WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180927 ↗
• MalfunctionJul 16, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, SEVENTY-THREE (73) BOXES OF .098¿ 9F 55CM VISTA BRITE TIP STRAIGHT (STR) GUIDING CATHETER HAD PARTICULATE MATTER MINUTE CARDBOARD SHAVINGS, FOUND INSIDE ITS STERILE POUCH. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. IT WAS DETECTED IN THE WAREHOUSE AND THE DEVICES NEVER MADE IT TO A HOSPITAL. THE ACTUAL PRODUCT WAS NOT DAMAGED. TOTAL OF SIX (6) DEVICES WILL BE RETURNED (2 FROM EACH LOT) WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180913 ↗
• MalfunctionFeb 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TWENTY-EIGHT (28) BOXES OF A .098¿ 9F 55CM VISTA BRITE TIP STRAIGHT (STR) GUIDING CATHETER HAD PARTICULATE MATTER OF SUSPECTED CARDBOARD FRAGMENTS FOUND INSIDE ITS STERILE POUCH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE PRODUCT WAS RECEIVED AND INSPECTED BY QUALITY CONTROL AT CUSTOMER¿S ON-SITE FACILITY. THE ACTUAL PRODUCT WAS NOT DAMAGED. THIS PRODUCT WAS NOT USED. IT WAS TAKEN OUT OF ITS BOX AND INSPECTED. IT WAS NOT INVOLVED IN ANY PROCEDURE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304658 ↗
• MalfunctionFeb 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TWENTY-EIGHT (28) BOXES OF A .098¿ 9F 55CM VISTA BRITE TIP STRAIGHT (STR) GUIDING CATHETER HAD PARTICULATE MATTER OF SUSPECTED CARDBOARD FRAGMENTS FOUND INSIDE ITS STERILE POUCH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE PRODUCT WAS RECEIVED AND INSPECTED BY QUALITY CONTROL AT CUSTOMER¿S ON-SITE FACILITY. THE ACTUAL PRODUCT WAS NOT DAMAGED. THIS PRODUCT WAS NOT USED. IT WAS TAKEN OUT OF ITS BOX AND INSPECTED. IT WAS NOT INVOLVED IN ANY PROCEDURE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304603 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F.098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671574 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671516 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671474 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671378 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671262 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671198 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671104 ↗
• MalfunctionOct 13, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671083 ↗
• MalfunctionOct 12, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10667077 ↗
• MalfunctionOct 12, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666693 ↗
• MalfunctionOct 12, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666496 ↗
• MalfunctionOct 12, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665631 ↗
• MalfunctionOct 12, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665446 ↗
• MalfunctionOct 12, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665356 ↗
• MalfunctionOct 12, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. PICTURES HAVE BEEN ATTACHED FOR REVIEW. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665286 ↗
• MalfunctionOct 12, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, PARTICLES (SUSPECT TINY CARDBOARD FRAGMENTS) WERE FOUND INSIDE STERILE POUCH OF 9F .098 STRAIGHT (STR) 55CM VISTA BRITE TIP GUIDING CATHETERS. SIXTEEN (16) BOXES WERE AFFECTED. THESE RECENT UNITS (16 IN TOTAL) WERE NOT INVOLVED IN ANY PROCEDURE. THEY WERE DISCOVERED DURING INSPECTION AT THE WAREHOUSE LEVEL. THEY WERE NOT EVEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665180 ↗
• MalfunctionFeb 11, 2019Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, THE 47 UNITS THAT WERE SITTING IN OUR WAREHOUSE WERE RELEASED AND 25 OF THEM WERE FOUND TO BE DEFECTIVE (PARTICULATE MATTER). THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE ACTUAL PRODUCT WAS NOT DAMAGED. THERE WAS NO DAMAGE TO THE OUTER PRODUCT BOX. THE 25 UNITS WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325489 ↗
• MalfunctionNov 27, 2018Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  AS REPORTED, THE CUSTOMER COMPLAINED OF PARTICLES BEING INSIDE STERILE FIELD OF PACKAGING. JUDGING BY PHOTOS, IT LOOKS AS IF THE CARDBOARD BACKING THAT THE GUIDE CATHETER IS ATTACHED TO WASN'T CLEANLY CUT AND SO THERE ARE FRAYS OF CARDBOARD. ACCORDING TO CUSTOMER: "WE¿RE INSPECTING OUR MOST RECENT SHIPMENT OF GUIDE CATHETERS, AND WE NOTICED THERE ARE SOME PARTICLES IN THE POUCHES. THEY ARE LIKELY FROM THE PAPERBOARD BACKING TO WHICH THE GUIDE CATHETER IS ATTACHED. I¿VE ATTACHED IMAGES THAT BEST EXEMPLIFIES THIS." THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE ACTUAL PRODUCT WAS NOT DAMAGED. THERE WAS NO DAMAGE TO THE OUTER PRODUCT BOX. IT IS UNKNOWN IF THERE WERE OTHER PARTICLES NOTED ELSEWHERE IN THE POUCH BESIDES WHAT WAS SHOWN IN THE PICTURES. TWO OF THE 64 DEVICES WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED FROM PRODUCT ANALYSIS INCLUDING THAT THE PARTICLES FOUND IN THE POUCH ARE FRAYS OF CARDBOARD THAT ARE STILL ATTACHED TO THE CARDBOARD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8105817 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992673. One submission often covers many models, so check the product and lot details in each record.

• Z-1198-2019 · Feb 7, 2019 · Terminated
  Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into