Catheter, Straight

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2023-06-08Open, ClassifiedUnder Investigation by firm

  Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818

  Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

• 2023-06-08Open, ClassifiedUnder Investigation by firm

  Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G

  Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

• 2023-06-08Open, ClassifiedUnder Investigation by firm

  Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G

  Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

• 2023-06-08Open, ClassifiedUnder Investigation by firm

  HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818

  Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

• 2018-04-04TerminatedProcess control

  HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

  Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

• 2018-04-04TerminatedProcess control

  Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.

  Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

• 2018-04-04TerminatedProcess control

  Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612G, 53614G, 53616G, 53618G, 62308, 62310, 62606P, 602608, 62608P, 62610, 62610P, 63310, 63316, 63610, 63610M, 63612, 63612M, 63614, 63614M, 63616, 63616M, 63618, 71410, 72608, 72610, 73612, 73614, 73616 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

  Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

• 2014-12-16TerminatedLabeling mix-ups

  Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage

  Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.

• 2012-10-02TerminatedLabeling mix-ups

  Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

  The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pouch and the case box labeled as M16Fr male, 16Fr, straight-tip catheters.

• 2011-06-03TerminatedIncorrect or no expiration date

  SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. 28022S 1400 SureCath Set,acc CH8 Male,bulk 28023S 1400 Surecath Set,acc CH10 Male,bul 28024S 1400 Surecath Set,acc CH12 Male,bul 280320 1400 SureCath Set,acc CH14 Male 28032S 1400 Surecath Set,acc CH14 Male,bul 28036S 1400 Surecath Set,acc CH14/1,2 Male 28037S 1400 Surecath Set,acc CH16 Male 280370 1400 Surecath Set,acc CH16 Male 28033S 1400 Surecath Set,acc CH16 Male 280360 1400 Surecath Set,acc CH14/1,2 Male 280340 1400 SURECATH SET W.ACC FEM14` The SureCath Set is indicated for use by patients for intermittent catherization for the purpose of bladder drainage. The insertion supplies provided are to be used to insert the catheter using sterile technique.

  Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the overall product expiration date. SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies are both packaged with a set of accessories which includes Iodine prep pads. The Iodine prep pads included i