ICU Medical 41239-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00840619043773), received between Feb 5, 2019 and Jun 19, 2019 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 reports).

5 other recalls cover devices cleared under the same FDA submission (K091268); 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE THAT INVOLVED A TORQUE-LINE CATHETER THAT THE CUSTOMER REPORTED THE CATHETER BALLOON RUPTURED DURING INSERTION. A PRE-INSERTION INFLATION TEST WAS DONE BEFORE THE CATHETER WAS INSERTED AND THE BALLOON WAS INTACT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION, AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711454 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER THAT THE CUSTOMER REPORTED THE CATHETER BALLOON RUPTURED DURING INSERTION OR DURING PATIENT USE. A PRE-INSERTION INFLATION TEST WAS DONE BEFORE THE CATHETER WAS INSERTED AND THE BALLOON WAS INTACT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION, AND NO DELAY IN CRITICAL THERAPY. THIS CAPTURES THE SEVENTH OF SEVEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711446 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER THAT THE CUSTOMER REPORTED THE CATHETER BALLOON RUPTURED DURING INSERTION OR DURING PATIENT USE. A PRE-INSERTION INFLATION TEST WAS DONE BEFORE THE CATHETER WAS INSERTED AND THE BALLOON WAS INTACT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION, AND NO DELAY IN CRITICAL THERAPY. THIS CAPTURES THE SIXTH OF SEVEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711444 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER THAT THE CUSTOMER REPORTED THE CATHETER BALLOON RUPTURED DURING INSERTION OR DURING PATIENT USE. A PRE-INSERTION INFLATION TEST WAS DONE BEFORE THE CATHETER WAS INSERTED AND THE BALLOON WAS INTACT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION, AND NO DELAY IN CRITICAL THERAPY. THIS CAPTURES THE FOURTH OF SEVEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711442 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER THAT THE CUSTOMER REPORTED THE CATHETER BALLOON RUPTURED DURING INSERTION OR DURING PATIENT USE. A PRE-INSERTION INFLATION TEST WAS DONE BEFORE THE CATHETER WAS INSERTED AND THE BALLOON WAS INTACT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION, AND NO DELAY IN CRITICAL THERAPY. THIS CAPTURES THE FIFTH OF SEVEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711441 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER THAT THE CUSTOMER REPORTED THE CATHETER BALLOON RUPTURED DURING INSERTION OR DURING PATIENT USE. A PRE-INSERTION INFLATION TEST WAS DONE BEFORE THE CATHETER WAS INSERTED AND THE BALLOON WAS INTACT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION, AND NO DELAY IN CRITICAL THERAPY. THIS CAPTURES THE THIRD OF SEVEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711434 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER THAT THE CUSTOMER REPORTED THE CATHETER BALLOON RUPTURED DURING INSERTION OR DURING PATIENT USE. A PRE-INSERTION INFLATION TEST WAS DONE BEFORE THE CATHETER WAS INSERTED AND THE BALLOON WAS INTACT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION, AND NO DELAY IN CRITICAL THERAPY. THIS CAPTURES THE FIRST OF SEVEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711430 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER THAT THE CUSTOMER REPORTED THE CATHETER BALLOON RUPTURED DURING INSERTION OR DURING PATIENT USE. A PRE-INSERTION INFLATION TEST WAS DONE BEFORE THE CATHETER WAS INSERTED AND THE BALLOON WAS INTACT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF HUMAN HARM, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION, AND NO DELAY IN CRITICAL THERAPY. THIS CAPTURES THE SECOND OF SEVEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711428 ↗
• MalfunctionMar 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING CARDIAC CATHETERIZATION THE BALLOON OF THE TD TORQUE-LINE CATHETER, 7F, RUPTURED DURING INSERTION. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT, NO DELAY IN CRITICAL THERAPY, NOR MEDICAL/SURGICAL INTERVENTION REQUIRED. THE DEVICE WAS CHANGED WITH NO FURTHER PROBLEMS ENCOUNTERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432861 ↗
• MalfunctionMar 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING CARDIAC CATHETERIZATION THE BALLOON OF THE TD TORQUE-LINE CATHETER, 7F, RUPTURED DURING INSERTION. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT, NO DELAY IN CRITICAL THERAPY, NOR MEDICAL / SURGICAL INTERVENTION REQUIRED. THE DEVICE WAS CHANGED WITH NO FURTHER PROBLEMS ENCOUNTERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432849 ↗
• MalfunctionMar 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING CARDIAC CATHETERIZATION THE BALLOON OF THE TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF RUPTURED DURING INSERTION. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT, NO DELAY IN CRITICAL THERAPY, NOR MEDICAL/SURGICAL INTERVENTION REQUIRED. THE DEVICE WAS CHANGED WITH NO FURTHER PROBLEMS ENCOUNTERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432833 ↗
• MalfunctionMar 7, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF, THAT DURING CARDIAC CATHETERIZATION, THE BALLOON RUPTURED. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO REPORT OF A SERIOUS INJURY/HARM, NO REPORT OF AN ADVERSE EVENT, AND NO REPORT OF DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8401857 ↗
• MalfunctionFeb 15, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, THAT DURING CARDIAC CATHETERIZATION THE BALLOON RUPTURED. THE CUSTOMER REPORTED THEY ROUTINELY PERFORM A ¿BALLOON UP¿ TEST SHORTLY AFTER IT¿S TAKEN OUT OF THE PACKAGE BY THE FELLOW WHO PRE-INFLATES THE BALLOON. THERE WAS PATIENT INVOLVEMENT BUT NO SERIOUS INJURY/HARM, NO ADVERSE EVENT, NO MEDICAL INTERVENTION REQUIRED, AND NO DELAY IN CRITICAL THERAPY. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345146 ↗
• MalfunctionFeb 15, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, THAT DURING CARDIAC CATHETERIZATION THE BALLOON RUPTURED. THE CUSTOMER REPORTED THEY ROUTINELY PERFORM A ¿BALLOON UP¿ TEST SHORTLY AFTER IT¿S TAKEN OUT OF THE PACKAGE BY THE FELLOW WHO PRE-INFLATES THE BALLOON. THERE WAS PATIENT INVOLVEMENT BUT NO SERIOUS INJURY/HARM, NO ADVERSE EVENT, NO MEDICAL INTERVENTION REQUIRED, AND NO DELAY IN CRITICAL THERAPY. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345133 ↗
• MalfunctionFeb 15, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF, THAT DURING CARDIAC CATHETERIZATION, THE BALLOON RUPTURED IN THE PATIENT. THERE WAS NO REPORTED DIFFICULTY NOTED DURING THE INSERTION. IT WAS ALSO REPORTED THAT AN 8 FR. CATHETER AND REPOSITIONING SLEEVE WAS USED DURING THE PROCEDURE. THEY ROUTINELY PERFORM A ¿BALLOON UP¿ TEST SHORTLY AFTER IT¿S TAKEN OUT OF THE PACKAGE BY THE FELLOW, WHO PRE-INFLATES THE BALLOON. THERE WAS NO SERIOUS INJURY/HARM, NO ADVERSE EVENT, NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344738 ↗
• MalfunctionFeb 15, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF, THAT DURING CARDIAC CATHETERIZATION, THE BALLOON RUPTURED IN THE PATIENT. THERE WAS NO REPORTED DIFFICULTY NOTED DURING THE INSERTION. IT WAS ALSO REPORTED THAT AN 8 FR. CATHETER AND REPOSITIONING SLEEVE WAS USED DURING THE PROCEDURE. THEY ROUTINELY PERFORM A ¿BALLOON UP¿ TEST SHORTLY AFTER IT¿S TAKEN OUT OF THE PACKAGE BY THE FELLOW, WHO PRE-INFLATES THE BALLOON. THERE WAS NO SERIOUS INJURY/HARM, NO ADVERSE EVENT, NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344687 ↗
• MalfunctionFeb 8, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVED A TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF, THAT DURING CARDIAC CATHETERIZATION, THE BALLOON RUPTURED IN THE PATIENT. THERE WAS NO REPORTED DIFFICULTY NOTED DURING THE INSERTION. IT WAS ALSO REPORTED THAT AN 8 FR. CATHETER AND REPOSITIONING SLEEVE WAS USED DURING THE PROCEDURE. THEY ROUTINELY PERFORM A ¿BALLOON UP¿ TEST SHORTLY AFTER IT¿S TAKEN OUT OF THE PACKAGE BY THE FELLOW, WHO PRE-INFLATES THE BALLOON. THERE WAS NO SERIOUS INJURY/HARM, NO ADVERSE EVENT, NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8322038 ↗
• MalfunctionFeb 6, 2019Material Rupture; Material Rupture

  THE REPORTER STATED, DURING A CARDIAC CATHETERIZATION THE BALLOON RUPTURED. IT WAS ALSO REPORTED THAT THE CUSTOMER HAS NOT MADE ANY CHANGES TO THEIR SHEATH SUPPLIER OR TYPE AND THEY ROUTINELY PERFORM A ¿BALLOON UP¿ TEST SHORTLY AFTER IT¿S TAKEN OUT OF THE PACKAGE. THERE WAS NO SERIOUS INJURY/HARM, NO ADVERSE EVENT, NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313423 ↗
• MalfunctionFeb 5, 2019Material Rupture; Material Rupture

  THE REPORTER STATED, DURING A CARDIAC CATHETERIZATION THE BALLOON RUPTURED. IT WAS ALSO REPORTED THAT THE CUSTOMER HAS NOT MADE ANY CHANGES TO THEIR SHEATH SUPPLIER OR TYPE AND THEY ROUTINELY PERFORM A ¿BALLOON UP¿ TEST SHORTLY AFTER IT¿S TAKEN OUT OF THE PACKAGE. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO SERIOUS INJURY/HARM, NO ADVERSE EVENT, NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN CRITICAL THERAPY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307571 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091268. One submission often covers many models, so check the product and lot details in each record.

• Z-2001-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1998-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1999-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1997-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-2000-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p